Clinical Performance Evaluation of AQT90 FLEX BNP and NT-proBNP

NCT ID: NCT01808872

Last Updated: 2014-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

569 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-05-31

Brief Summary

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The AQT90 FLEX B-type Natriuretic Peptide (BNP) and N-terminal pro B-type natriuretic peptide (NT-proBNP) Tests are in vitro diagnostic assays intended as an aid in the diagnosis and assessment of the severity of heart failure in point-of-care and laboratory settings. The purpose of the study is to establish the clinical performance of the AQT90 FLEX BNP and NT-proBNP assays for both whole blood and plasma in the intended use population.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Heart Failure

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject is 21 years of age or older
* Subject is able to understand information given, and willing and able to voluntarily give their consent to participate in this study
* Subject has diagnosis of heart failure

Exclusion Criteria

* Subject has Acute Coronary Syndrome (ACS)
* Subject has been diagnosed and/or treated for malignancy within past 6 months
* Subject has had cardiac surgery within the past 4 weeks
* Subject claim of pregnancy
* Subject's prior participation in this study
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radiometer Medical ApS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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DC-043652

Identifier Type: -

Identifier Source: org_study_id

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